Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial.

Pratley RE, Aroda VR, Lingvay I, Lüdemann J, Andreassen C, Navarria A, Viljoen A

The lancet. Diabetes & endocrinology1 Feb 2018Cited by 614 (Europe PMC)

PMID29397376DOI10.1016/s2213-8587(18)30024-xPepBankPUB-29397376

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Summary

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Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study21

21 results from studies that gave the peptide. 21 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin, semaglutide 0.5 mg lowered HbA1c more than dulaglutide 0.75 mg at week 40.
In plain wordsIn adults with type 2 diabetes, semaglutide 0.5 mg lowered HbA1c more than dulaglutide 0.75 mg.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change at week 40
Study
n = 301
Comparator
Dulaglutide 0.75 mg
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.5 mg once weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
HbA1c change
−1.5 percentage points
semaglutide 0.5 mg
HbA1c change
−1.1 percentage points
dulaglutide 0.75 mg
Estimated treatment difference
−0.4 percentage points
vs dulaglutide 0.75 mg
Source sentences
Summary
From overall baseline mean, mean percentage HbA_1c was reduced by 1·5 (SE 0·06) percentage points with semaglutide 0·5 mg versus 1·1 (0·05) percentage points with dulaglutide 0·75 mg (estimated treatment difference [ETD] -0·40 percentage points [95% CI -0·55 to -0·25]; p<0·0001)
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were randomly assigned (1:1:1:1) by use of an interactive web-response system to once a week treatment with either semaglutide 0·5 mg, dulaglutide 0·75 mg, semaglutide 1·0 mg, or dulaglutide 1·5 mg subcutaneously.
Report a problemFND-2939737601
02HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin, semaglutide 1.0 mg lowered HbA1c more than dulaglutide 1.5 mg at week 40.
In plain wordsIn adults with type 2 diabetes, semaglutide 1.0 mg lowered HbA1c more than dulaglutide 1.5 mg.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change at week 40
Study
n = 300
Comparator
Dulaglutide 1.5 mg
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.0 mg once weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
HbA1c change
−1.8 percentage points
semaglutide 1.0 mg
HbA1c change
−1.4 percentage points
dulaglutide 1.5 mg
Estimated treatment difference
−0.41 percentage points
vs dulaglutide 1.5 mg
Source sentences
Summary
and by 1·8 (0·06) percentage points with semaglutide 1·0 mg versus 1·4 (0·06) percentage points with dulaglutide 1·5 mg (ETD -0·41 percentage points [-0·57 to -0·25]; p<0·0001).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were randomly assigned (1:1:1:1) by use of an interactive web-response system to once a week treatment with either semaglutide 0·5 mg, dulaglutide 0·75 mg, semaglutide 1·0 mg, or dulaglutide 1·5 mg subcutaneously.
Report a problemFND-2939737602
03HumanRandomized controlled trialEfficacy outcome
In patients with diabetes, dulaglutide 0.75 mg reduced HbA1c less than semaglutide 0.5 mg.
In plain wordsIn patients with diabetes, dulaglutide 0.75 mg reduced HbA1c less than semaglutide 0.5 mg.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseHbA1c at low dose
Study
n: not reported in source
Comparator
Semaglutide 0.5 mg weekly
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.75 mg weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
HbA1c reduction
1.1 percentage points
dulaglutide 0.75 mg, SE 0.05
HbA1c reduction
1.5 percentage points
semaglutide 0.5 mg, SE 0.06
Estimated treatment difference in HbA1c
−0.4 percentage points
semaglutide 0.5 mg versus dulaglutide 0.75 mg, 95% CI -0.55 to -0.25
95% CI
−0.55 to −0.25 percentage points
semaglutide 0.5 mg versus dulaglutide 0.75 mg
Source sentences
Summary
From overall baseline mean, mean percentage HbA_1c was reduced by 1·5 (SE 0·06) percentage points with semaglutide 0·5 mg versus 1·1 (0·05) percentage points with dulaglutide 0·75 mg (estimated treatment difference [ETD] -0·40 percentage points [95% CI -0·55 to -0·25]; p<0·0001)
2 context sentences(design, population, supporting numbers)
Summary · context
Eligible patients were aged 18 years or older and had type 2 diabetes with HbA_1c 7·0-10·5% (53·0-91·0 mmol/mol) on metformin monotherapy.
Summary · context
Patients were randomly assigned (1:1:1:1) by use of an interactive web-response system to once a week treatment with either semaglutide 0·5 mg, dulaglutide 0·75 mg, semaglutide 1·0 mg, or dulaglutide 1·5 mg subcutaneously.
Report a problemFND-2939737613
04HumanRandomized controlled trialEfficacy outcome
In patients with diabetes, dulaglutide 1.5 mg reduced HbA1c less than semaglutide 1.0 mg.
In plain wordsIn patients with diabetes, dulaglutide 1.5 mg reduced HbA1c less than semaglutide 1.0 mg.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseHbA1c at high dose
Study
n: not reported in source
Comparator
Semaglutide 1.0 mg weekly
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
HbA1c reduction
1.4 percentage points
dulaglutide 1.5 mg, SE 0.06
HbA1c reduction
1.8 percentage points
semaglutide 1.0 mg, SE 0.06
Estimated treatment difference in HbA1c
−0.41 percentage points
semaglutide 1.0 mg versus dulaglutide 1.5 mg, 95% CI -0.57 to -0.25
95% CI
−0.57 to −0.25 percentage points
semaglutide 1.0 mg versus dulaglutide 1.5 mg
Source sentences
Summary
and by 1·8 (0·06) percentage points with semaglutide 1·0 mg versus 1·4 (0·06) percentage points with dulaglutide 1·5 mg (ETD -0·41 percentage points [-0·57 to -0·25]; p<0·0001).
2 context sentences(design, population, supporting numbers)
Summary · context
Eligible patients were aged 18 years or older and had type 2 diabetes with HbA_1c 7·0-10·5% (53·0-91·0 mmol/mol) on metformin monotherapy.
Summary · context
Patients were randomly assigned (1:1:1:1) by use of an interactive web-response system to once a week treatment with either semaglutide 0·5 mg, dulaglutide 0·75 mg, semaglutide 1·0 mg, or dulaglutide 1·5 mg subcutaneously.
Report a problemFND-2939737614
05HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin, semaglutide 0.5 mg reduced body weight more than dulaglutide 0.75 mg at week 40.
In plain wordsIn adults with type 2 diabetes, semaglutide 0.5 mg led to more weight loss than dulaglutide 0.75 mg.
Peptide
Semaglutide
Outcome
DecreaseBody weight change at week 40
Study
n = 301
Comparator
Dulaglutide 0.75 mg
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
0.5 mg once weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
Body weight change
−4.6 kg
semaglutide 0.5 mg
Body weight change
−2.3 kg
dulaglutide 0.75 mg
Estimated treatment difference
−2.26 kg
vs dulaglutide 0.75 mg
Source sentences
Summary
From overall baseline mean, mean bodyweight was reduced by 4·6 kg (SE 0·28) with semaglutide 0·5 mg compared with 2·3 kg (0·27) with dulaglutide 0·75 mg (ETD -2·26 kg [-3·02 to -1·51]; p<0·0001)
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were randomly assigned (1:1:1:1) by use of an interactive web-response system to once a week treatment with either semaglutide 0·5 mg, dulaglutide 0·75 mg, semaglutide 1·0 mg, or dulaglutide 1·5 mg subcutaneously.
Report a problemFND-2939737603
06HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin, semaglutide 1.0 mg reduced body weight more than dulaglutide 1.5 mg at week 40.
In plain wordsIn adults with type 2 diabetes, semaglutide 1.0 mg led to more weight loss than dulaglutide 1.5 mg.
Peptide
Semaglutide
Outcome
DecreaseBody weight change at week 40
Study
n = 300
Comparator
Dulaglutide 1.5 mg
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
1.0 mg once weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
Body weight change
−6.5 kg
semaglutide 1.0 mg
Body weight change
−3 kg
dulaglutide 1.5 mg
Estimated treatment difference
−3.55 kg
vs dulaglutide 1.5 mg
Source sentences
Summary
and by 6·5 kg (0·28) with semaglutide 1·0 mg compared with 3·0 kg (0·27) with dulaglutide 1·5 mg (ETD -3·55 kg [-4·32 to -2·78]; p<0·0001).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were randomly assigned (1:1:1:1) by use of an interactive web-response system to once a week treatment with either semaglutide 0·5 mg, dulaglutide 0·75 mg, semaglutide 1·0 mg, or dulaglutide 1·5 mg subcutaneously.
Report a problemFND-2939737604
07HumanRandomized controlled trialEfficacy outcome
In patients with diabetes, dulaglutide 0.75 mg reduced bodyweight less than semaglutide 0.5 mg.
In plain wordsIn patients with diabetes, dulaglutide 0.75 mg reduced weight less than semaglutide 0.5 mg.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseBodyweight at low dose
Study
n: not reported in source
Comparator
Semaglutide 0.5 mg weekly
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
0.75 mg weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
Bodyweight reduction
2.3 kg
dulaglutide 0.75 mg, SE 0.27
Bodyweight reduction
4.6 kg
semaglutide 0.5 mg, SE 0.28
Estimated treatment difference in bodyweight
−2.26 kg
semaglutide 0.5 mg versus dulaglutide 0.75 mg, 95% CI -3.02 to -1.51
95% CI
−3.02 to −1.51 kg
semaglutide 0.5 mg versus dulaglutide 0.75 mg
Source sentences
Summary
From overall baseline mean, mean bodyweight was reduced by 4·6 kg (SE 0·28) with semaglutide 0·5 mg compared with 2·3 kg (0·27) with dulaglutide 0·75 mg (ETD -2·26 kg [-3·02 to -1·51]; p<0·0001)
2 context sentences(design, population, supporting numbers)
Summary · context
Eligible patients were aged 18 years or older and had type 2 diabetes with HbA_1c 7·0-10·5% (53·0-91·0 mmol/mol) on metformin monotherapy.
Summary · context
Patients were randomly assigned (1:1:1:1) by use of an interactive web-response system to once a week treatment with either semaglutide 0·5 mg, dulaglutide 0·75 mg, semaglutide 1·0 mg, or dulaglutide 1·5 mg subcutaneously.
Report a problemFND-2939737615
08HumanRandomized controlled trialEfficacy outcome
In patients with diabetes, dulaglutide 1.5 mg reduced bodyweight less than semaglutide 1.0 mg.
In plain wordsIn patients with diabetes, dulaglutide 1.5 mg reduced weight less than semaglutide 1.0 mg.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseBodyweight at high dose
Study
n: not reported in source
Comparator
Semaglutide 1.0 mg weekly
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
1.5 mg weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
Bodyweight reduction
3 kg
dulaglutide 1.5 mg, SE 0.27
Bodyweight reduction
6.5 kg
semaglutide 1.0 mg, SE 0.28
Estimated treatment difference in bodyweight
−3.55 kg
semaglutide 1.0 mg versus dulaglutide 1.5 mg, 95% CI -4.32 to -2.78
95% CI
−4.32 to −2.78 kg
semaglutide 1.0 mg versus dulaglutide 1.5 mg
Source sentences
Summary
and by 6·5 kg (0·28) with semaglutide 1·0 mg compared with 3·0 kg (0·27) with dulaglutide 1·5 mg (ETD -3·55 kg [-4·32 to -2·78]; p<0·0001).
2 context sentences(design, population, supporting numbers)
Summary · context
Eligible patients were aged 18 years or older and had type 2 diabetes with HbA_1c 7·0-10·5% (53·0-91·0 mmol/mol) on metformin monotherapy.
Summary · context
Patients were randomly assigned (1:1:1:1) by use of an interactive web-response system to once a week treatment with either semaglutide 0·5 mg, dulaglutide 0·75 mg, semaglutide 1·0 mg, or dulaglutide 1·5 mg subcutaneously.
Report a problemFND-2939737616
09HumanRandomized controlled trialSafety outcome
One death occurred in each semaglutide group.
In plain wordsOne person died in each of the two semaglutide groups.
Peptide
Semaglutide
Outcome
Not applicableDeaths in semaglutide groups
Study
n = 601
Outcome group
Mortality · Whole body
Studied dose
0.5 mg and 1.0 mg once weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
Deaths
1 patients
each semaglutide group
Source sentences
Summary
There were six fatalities: one in each semaglutide group and two in each dulaglutide group.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were randomly assigned (1:1:1:1) by use of an interactive web-response system to once a week treatment with either semaglutide 0·5 mg, dulaglutide 0·75 mg, semaglutide 1·0 mg, or dulaglutide 1·5 mg subcutaneously.
Report a problemFND-2939737610
10HumanRandomized controlled trialSafety outcome
In patients with diabetes, gastrointestinal disorders were the most common reason for stopping dulaglutide treatment.
In plain wordsIn patients with diabetes, digestive adverse events were the most common reason for stopping dulaglutide treatment.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedDiscontinuation due to gastrointestinal disorders
Study
n = 598
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.75 mg or 1.5 mg weekly · subcutaneous · 40 weeksAs given in this study (human).
Source sentences
Summary
Gastrointestinal disorders were also the most common reason for discontinuing treatment with semaglutide and dulaglutide.
2 context sentences(design, population, supporting numbers)
Summary · context
Eligible patients were aged 18 years or older and had type 2 diabetes with HbA_1c 7·0-10·5% (53·0-91·0 mmol/mol) on metformin monotherapy.
Summary · context
Patients were randomly assigned (1:1:1:1) by use of an interactive web-response system to once a week treatment with either semaglutide 0·5 mg, dulaglutide 0·75 mg, semaglutide 1·0 mg, or dulaglutide 1·5 mg subcutaneously.
Report a problemFND-2939737619
11HumanRandomized controlled trialSafety outcome
Gastrointestinal disorders occurred in 43% of patients on semaglutide 0.5 mg and 33% on dulaglutide 0.75 mg.
In plain wordsStomach and gut side effects occurred in more patients on semaglutide 0.5 mg than on dulaglutide 0.75 mg.
Peptide
Semaglutide
Outcome
IncreaseGastrointestinal disorders
Study
n = 301
Comparator
Dulaglutide 0.75 mg
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.5 mg once weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
Gastrointestinal disorders
43%
semaglutide 0.5 mg
Gastrointestinal disorders
33%
dulaglutide 0.75 mg
Source sentences
Summary
Gastrointestinal disorders were the most frequently reported adverse event, occurring in 129 (43%) of 301 patients receiving semaglutide 0·5 mg, 133 (44%) of 300 patients receiving semaglutide 1·0 mg, 100 (33%) of 299 patients receiving dulaglutide 0·75 mg, and in 143 (48%) of 299 patients receiving dulaglutide 1·5 mg.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were randomly assigned (1:1:1:1) by use of an interactive web-response system to once a week treatment with either semaglutide 0·5 mg, dulaglutide 0·75 mg, semaglutide 1·0 mg, or dulaglutide 1·5 mg subcutaneously.
Report a problemFND-2939737605
12HumanRandomized controlled trialSafety outcome
More patients withdrew from the trial on semaglutide 0.5 mg (22) than on dulaglutide 0.75 mg (13).
In plain wordsMore patients withdrew on semaglutide 0.5 mg than on dulaglutide 0.75 mg, with small numbers in each group.
Peptide
Semaglutide
Outcome
IncreaseTrial withdrawal
Study
n = 301
Comparator
Dulaglutide 0.75 mg
Outcome group
Adverse events · Whole body
Studied dose
0.5 mg once weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
Withdrawals
22 patients
semaglutide 0.5 mg
Withdrawals
13 patients
dulaglutide 0.75 mg
Source sentences
Summary
72 (6%) patients withdrew from the trial (22 receiving semaglutide 0·5 mg, 13 receiving dulaglutide 0·75 mg, 21 receiving semaglutide 1·0 mg, and 16 receiving dulaglutide 1·5 mg).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were randomly assigned (1:1:1:1) by use of an interactive web-response system to once a week treatment with either semaglutide 0·5 mg, dulaglutide 0·75 mg, semaglutide 1·0 mg, or dulaglutide 1·5 mg subcutaneously.
Report a problemFND-2939737607
13HumanRandomized controlled trialSafety outcome
Gastrointestinal disorders occurred in 44% of patients on semaglutide 1.0 mg and 48% on dulaglutide 1.5 mg.
In plain wordsStomach and gut side effects occurred in slightly fewer patients on semaglutide 1.0 mg than on dulaglutide 1.5 mg.
Peptide
Semaglutide
Outcome
DecreaseGastrointestinal disorders
Study
n = 300
Comparator
Dulaglutide 1.5 mg
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.0 mg once weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
Gastrointestinal disorders
44%
semaglutide 1.0 mg
Gastrointestinal disorders
48%
dulaglutide 1.5 mg
Source sentences
Summary
Gastrointestinal disorders were the most frequently reported adverse event, occurring in 129 (43%) of 301 patients receiving semaglutide 0·5 mg, 133 (44%) of 300 patients receiving semaglutide 1·0 mg, 100 (33%) of 299 patients receiving dulaglutide 0·75 mg, and in 143 (48%) of 299 patients receiving dulaglutide 1·5 mg.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were randomly assigned (1:1:1:1) by use of an interactive web-response system to once a week treatment with either semaglutide 0·5 mg, dulaglutide 0·75 mg, semaglutide 1·0 mg, or dulaglutide 1·5 mg subcutaneously.
Report a problemFND-2939737606
14HumanRandomized controlled trialSafety outcome
More patients withdrew from the trial on semaglutide 1.0 mg (21) than on dulaglutide 1.5 mg (16).
In plain wordsMore patients withdrew on semaglutide 1.0 mg than on dulaglutide 1.5 mg, with small numbers in each group.
Peptide
Semaglutide
Outcome
IncreaseTrial withdrawal
Study
n = 300
Comparator
Dulaglutide 1.5 mg
Outcome group
Adverse events · Whole body
Studied dose
1.0 mg once weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
Withdrawals
21 patients
semaglutide 1.0 mg
Withdrawals
16 patients
dulaglutide 1.5 mg
Source sentences
Summary
72 (6%) patients withdrew from the trial (22 receiving semaglutide 0·5 mg, 13 receiving dulaglutide 0·75 mg, 21 receiving semaglutide 1·0 mg, and 16 receiving dulaglutide 1·5 mg).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were randomly assigned (1:1:1:1) by use of an interactive web-response system to once a week treatment with either semaglutide 0·5 mg, dulaglutide 0·75 mg, semaglutide 1·0 mg, or dulaglutide 1·5 mg subcutaneously.
Report a problemFND-2939737608
15HumanRandomized controlled trialOther
In patients with diabetes, 13 dulaglutide low-dose recipients withdrew from the trial.
In plain wordsIn patients with diabetes, 13 dulaglutide low-dose recipients withdrew from the trial.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableTrial withdrawal at low dose
Study
n = 299
Outcome group
Treatment adherence and retention · Whole body
Studied dose
0.75 mg weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
Trial withdrawals
13 patients
dulaglutide 0.75 mg
Source sentences
Summary
72 (6%) patients withdrew from the trial (22 receiving semaglutide 0·5 mg, 13 receiving dulaglutide 0·75 mg, 21 receiving semaglutide 1·0 mg, and 16 receiving dulaglutide 1·5 mg).
2 context sentences(design, population, supporting numbers)
Summary · context
Eligible patients were aged 18 years or older and had type 2 diabetes with HbA_1c 7·0-10·5% (53·0-91·0 mmol/mol) on metformin monotherapy.
Summary · context
Patients were randomly assigned (1:1:1:1) by use of an interactive web-response system to once a week treatment with either semaglutide 0·5 mg, dulaglutide 0·75 mg, semaglutide 1·0 mg, or dulaglutide 1·5 mg subcutaneously.
Report a problemFND-2939737611
16HumanRandomized controlled trialOther
In patients with diabetes, 16 dulaglutide high-dose recipients withdrew from the trial.
In plain wordsIn patients with diabetes, 16 dulaglutide high-dose recipients withdrew from the trial.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableTrial withdrawal at high dose
Study
n = 299
Outcome group
Treatment adherence and retention · Whole body
Studied dose
1.5 mg weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
Trial withdrawals
16 patients
dulaglutide 1.5 mg
Source sentences
Summary
72 (6%) patients withdrew from the trial (22 receiving semaglutide 0·5 mg, 13 receiving dulaglutide 0·75 mg, 21 receiving semaglutide 1·0 mg, and 16 receiving dulaglutide 1·5 mg).
2 context sentences(design, population, supporting numbers)
Summary · context
Eligible patients were aged 18 years or older and had type 2 diabetes with HbA_1c 7·0-10·5% (53·0-91·0 mmol/mol) on metformin monotherapy.
Summary · context
Patients were randomly assigned (1:1:1:1) by use of an interactive web-response system to once a week treatment with either semaglutide 0·5 mg, dulaglutide 0·75 mg, semaglutide 1·0 mg, or dulaglutide 1·5 mg subcutaneously.
Report a problemFND-2939737612
17HumanRandomized controlled trialSafety outcome
In patients with diabetes, gastrointestinal disorders occurred in 100 dulaglutide 0.75 mg recipients.
In plain wordsIn patients with diabetes, 100 dulaglutide 0.75 mg recipients had digestive adverse events.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableGastrointestinal disorders at low dose
Study
n = 299
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.75 mg weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
Gastrointestinal disorders
100 patients
dulaglutide 0.75 mg, of 299
Gastrointestinal disorders
33%
dulaglutide 0.75 mg
Source sentences
Summary
Gastrointestinal disorders were the most frequently reported adverse event, occurring in 129 (43%) of 301 patients receiving semaglutide 0·5 mg, 133 (44%) of 300 patients receiving semaglutide 1·0 mg, 100 (33%) of 299 patients receiving dulaglutide 0·75 mg, and in 143 (48%) of 299 patients receiving dulaglutide 1·5 mg.
2 context sentences(design, population, supporting numbers)
Summary · context
Eligible patients were aged 18 years or older and had type 2 diabetes with HbA_1c 7·0-10·5% (53·0-91·0 mmol/mol) on metformin monotherapy.
Summary · context
Patients were randomly assigned (1:1:1:1) by use of an interactive web-response system to once a week treatment with either semaglutide 0·5 mg, dulaglutide 0·75 mg, semaglutide 1·0 mg, or dulaglutide 1·5 mg subcutaneously.
Report a problemFND-2939737617
18HumanRandomized controlled trialSafety outcome
In patients with diabetes, gastrointestinal disorders occurred in 143 dulaglutide 1.5 mg recipients.
In plain wordsIn patients with diabetes, 143 dulaglutide 1.5 mg recipients had digestive adverse events.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableGastrointestinal disorders at high dose
Study
n = 299
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.5 mg weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
Gastrointestinal disorders
143 patients
dulaglutide 1.5 mg, of 299
Gastrointestinal disorders
48%
dulaglutide 1.5 mg
Source sentences
Summary
Gastrointestinal disorders were the most frequently reported adverse event, occurring in 129 (43%) of 301 patients receiving semaglutide 0·5 mg, 133 (44%) of 300 patients receiving semaglutide 1·0 mg, 100 (33%) of 299 patients receiving dulaglutide 0·75 mg, and in 143 (48%) of 299 patients receiving dulaglutide 1·5 mg.
2 context sentences(design, population, supporting numbers)
Summary · context
Eligible patients were aged 18 years or older and had type 2 diabetes with HbA_1c 7·0-10·5% (53·0-91·0 mmol/mol) on metformin monotherapy.
Summary · context
Patients were randomly assigned (1:1:1:1) by use of an interactive web-response system to once a week treatment with either semaglutide 0·5 mg, dulaglutide 0·75 mg, semaglutide 1·0 mg, or dulaglutide 1·5 mg subcutaneously.
Report a problemFND-2939737618
19HumanRandomized controlled trialSafety outcome
In patients with diabetes, two patients died in the dulaglutide 0.75 mg group.
In plain wordsIn patients with diabetes, two patients died in the dulaglutide 0.75 mg group.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableDeaths at low dose
Study
n = 299
Outcome group
Mortality · Whole body
Studied dose
0.75 mg weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
Deaths
2 patients
dulaglutide 0.75 mg group
Source sentences
Summary
There were six fatalities: one in each semaglutide group and two in each dulaglutide group.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomly assigned (1:1:1:1) by use of an interactive web-response system to once a week treatment with either semaglutide 0·5 mg, dulaglutide 0·75 mg, semaglutide 1·0 mg, or dulaglutide 1·5 mg subcutaneously.
Summary · context
Eligible patients were aged 18 years or older and had type 2 diabetes with HbA_1c 7·0-10·5% (53·0-91·0 mmol/mol) on metformin monotherapy.
Report a problemFND-2939737620
20HumanRandomized controlled trialSafety outcome
In patients with diabetes, two patients died in the dulaglutide 1.5 mg group.
In plain wordsIn patients with diabetes, two patients died in the dulaglutide 1.5 mg group.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableDeaths at high dose
Study
n = 299
Outcome group
Mortality · Whole body
Studied dose
1.5 mg weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
Deaths
2 patients
dulaglutide 1.5 mg group
Source sentences
Summary
There were six fatalities: one in each semaglutide group and two in each dulaglutide group.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomly assigned (1:1:1:1) by use of an interactive web-response system to once a week treatment with either semaglutide 0·5 mg, dulaglutide 0·75 mg, semaglutide 1·0 mg, or dulaglutide 1·5 mg subcutaneously.
Summary · context
Eligible patients were aged 18 years or older and had type 2 diabetes with HbA_1c 7·0-10·5% (53·0-91·0 mmol/mol) on metformin monotherapy.
Report a problemFND-2939737621
21HumanRandomized controlled trialSafety outcome
Gastrointestinal disorders were the most common reason for stopping semaglutide, and also dulaglutide.
In plain wordsStomach and gut problems were the most common reason people stopped semaglutide, and also dulaglutide.
Peptide
Semaglutide
Outcome
Not applicableReason for discontinuing treatment
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.5 mg and 1.0 mg once weekly · subcutaneous · 40 weeksAs given in this study (human).
Source sentences
Summary
Gastrointestinal disorders were also the most common reason for discontinuing treatment with semaglutide and dulaglutide.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were randomly assigned (1:1:1:1) by use of an interactive web-response system to once a week treatment with either semaglutide 0·5 mg, dulaglutide 0·75 mg, semaglutide 1·0 mg, or dulaglutide 1·5 mg subcutaneously.
Report a problemFND-2939737609

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials4

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

4 trials · 2 ongoing · 2 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

RecruitingPhase 3NCT06894784

A Clinical Trial to Evaluate The Effects of Semaglutide and Empagliflozin Combined to Automated Insulin Delivery on Diabetes Control in Adults Living With Type 1 Diabetes

McGill University Health Centre/Research Institute of the McGill University Health Centren = 36est. Apr 2025 to est. Jan 2027

Diabetes Type 1

Trial page ClinicalTrials.govUpdated 30 Mar 2025

RecruitingPhase not statedNCT06686134

Comprehensive Clinical Evaluation Study of GLP-1RA

LI YANn = 4921 Jul 2024 to est. 31 Jul 2026

T2DM

Trial page ClinicalTrials.govUpdated 13 Nov 2024

CompletedPhase not statedNCT05136287

SEMAGLUTIDE VERSUS GLP-1 RECEPTOR AGONISTS. EFFECTIVENESS , SAFETY AND QUALITY OF LIFE IN PATIENTS WITH DIABETES MELLITUS 2. OBSERVATIONAL, PROSPECTIVE AND MULTICENTER STUDY. SEVERAL STUDY.

Jose Seijas Amigon = 1401 Feb 2022 to 1 Jan 2024

Weight Loss · Diabetes Mellitus, Type 2 · Quality of Life · Safety Issues

Trial page ClinicalTrials.govUpdated 28 Feb 2024

CompletedPhase 3Results postedNCT02648204

Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes.

Novo Nordisk A/Sn = 1,2016 Jan 2016 to 19 May 2017

Diabetes · Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 15 Oct 2019

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Versions 4 to 9Current
28 Oct 2026, 02:03 UTC
The same notice was added 6 times, first on 22 Oct 2026, 02:26 UTC. The status did not change between them.
Study results updated
Version 3
21 Oct 2026, 18:59 UTC
Study data updated · source update from Europe PMC
Version 2
11 Oct 2026, 00:50 UTC
Study results updated
Version 1
9 Oct 2026, 03:06 UTC
First added · source update from Europe PMC